Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence

Inclusion Criteria:

- Has female stress urinary incontinence that is due to intrinsic sphincter deficiency

- Has a baseline pad weight of greater than or equal to 50 grams

- Has viable mucosal lining at likely site of injection (bladder neck)

- Is at least 18 years of age

- Understands and accepts the obligation and is logistically able to present for all
scheduled study visits

- Signs written informed consent

Exclusion Criteria:

- Has had a previous treatment for urinary incontinence with a urethral bulking agent
other than Coaptite® or collagen

- Has detrusor instability

- Has bladder neuropathy

- Has nocturnal enuresis (bed wetting)

- Has Grade II or III prolapsed bladder

- Has overflow or functional incontinence

- Has significant history of urinary tract infections without resolution

- Has current or acute conditions of cystitis or urethritis

- Has history of significant pelvic irradiation

- Is pregnant or lactating